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1.
Pharm Stat ; 21(4): 764-777, 2022 07.
Article in English | MEDLINE | ID: covidwho-1929591

ABSTRACT

Andy Grieve, the first pharmaceutical statistician to be President of the Royal Statistical Society, practiced in the regulated world of drug development. With reduction in drug development costs as his motivation, Grieve advanced Bayesian methods for developing predictive methods for efficacy and toxicity - to be used as early as possible in the drug development process; and his presidential address exhorted statisticians to weigh-in wherever data are used to make decisions. Diagnostic tests for infectious diseases are less regulated than drugs and vaccines unless the blood supply is at risk. Unlike in the HIV and HCV pandemics of the late 20th century, even well-designed surveys linked to a volunteered biological sample (to be tested for SARS-CoV-2 antigen or antibodies) have had modest or low consent rates. Record-linkage, statistical design and reporting standards have seen triumph and tragedy. Among the triumphs are: Liverpool's insistence on dual testing (lateral flow device; polymerase chain reaction [PCR]) of some 6000 asymptomatic citizens who attended for SARS-CoV-2-screening; two tricky randomized controlled public-policy trials on daily contact testing for close contacts of index cases of SARS-CoV-2 infection versus self-isolation (with or without initial PCR); and among already-consented participants in surveillance, over 80% secondary consent for linkage to their health records, including the Immunization Management Service. Before the next pandemic we need to entrench better regulation of diagnostic tests, better informed consent (not via weblinks), better feedback to participants, and transparency about basic safety data.


Subject(s)
COVID-19 , Pandemics , Bayes Theorem , COVID-19/epidemiology , COVID-19/prevention & control , Humans , Pandemics/prevention & control , Pharmacovigilance , SARS-CoV-2
2.
J Public Health (Oxf) ; 2022 Feb 04.
Article in English | MEDLINE | ID: covidwho-1684779

ABSTRACT

BACKGROUND: Twice weekly lateral flow tests (LFTs) for secondary school children was UK Government policy from 8 March 2021. We evaluate use of LFTs (both supervised at test centres, and home test kits) in school-aged children in Cheshire and Merseyside. METHODS: We report (i) number of LFT positives (ii) proportion of LFT positive with confirmatory reverse transcription polymerase chain reaction (PCR) test within 2 days, and (iii) agreement between LFT-positive and confirmatory PCR, and dependence of (i-iii) on COVID-19 prevalence. FINDINGS: 1 248 468 LFTs were taken by 211 255 12-18 years old, and 163 914 by 52 116 5-11 years old between 6 November 2020 and 31 July 2021. Five thousand three hundred and fourteen (2.5%) 12-18 years old and 1996 (3.8%) 5-11 years old returned LFT positives, with 3829 (72.1%) and 1535 (76.9%) confirmatory PCRs, and 3357 (87.7%) and 1383 (90.1%) confirmatory PCR-positives, respectively.Monthly proportions of LFT positive with PCR negative varied between 4.7% and 35.3% in 12-18 years old (corresponding proportion of all tests positive: 9.7% and 0.3%).Deprivation and non-White ethnicity were associated with reduced uptake of confirmatory PCR. INTERPRETATION: Substantial inequalities in confirmatory testing need more attention to avoid further disadvantage through education loss. When prevalence is low additional measures, including confirmatory testing, are needed. Local Directors of Public Health taking more control over schools testing may be needed. FUNDING: DHSC, MRC, NIHR, EPSRC.

3.
Signif (Oxf) ; 19(1): 4-5, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1672902

ABSTRACT

When Sheila M. Bird agreed to participate in a Covid surveillance study, she did not realise her negative test result and personal details would be passed to NHS Test and Trace. Here, she calls for closer scrutiny of privacy policies by research ethics committees, and clearer communication with study participants.

4.
Signif (Oxf) ; 18(3): 42-45, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1243584

ABSTRACT

Sheila Bird offers a personal account of the debate over rapid coronavirus screening in secondary schools, and the efforts to reinstate confirmatory PCR tests.

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